Associate Software Project Manager

HISTOSONICS INC•Plymouth, MN

7h•$130,000 - $150,000•Onsite

About The Position

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties. We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most. Location: Plymouth, MN Position Summary (Why this role matters): The Associate Software Project Manager coordinates the planning and execution of software releases for the Edison system. This role drives cross-functional alignment across software engineering, quality, regulatory, product development, and systems engineering teams to deliver software releases and supporting documentation that meet business objectives, regulatory requirements, and program milestones.

Requirements

Bachelor’s degree in computer engineering, computer science, software engineering, or a closely related technical field
5+ years of software experience in a regulated industry; preferably medical device
2-3 years of experience leading software delivery teams
Experience planning or coordinating complex software releases involving multiple teams, dependencies, and regulatory deliverables
Experience maintaining project dashboards, and tracking work using Jira, Azure DevOps, or similar tools
Ability to collaborate across matrixed organizations, communicate technical status and risks effectively, and drive alignment without direct authority
Understanding of phase-gate or milestone-based product development in regulated environments
Experience supporting FDA-regulated software development and familiarity with standards and regulations applicable to medical device software, including IEC 62304

Nice To Haves

Certified Scrum Master (CSM, CSP-SM), PMI-ACP, or equivalent Agile certification preferred

Responsibilities

Coordinate software project execution across feasibility, development, verification, validation, and release activities
Drive cross-functional alignment on scope, priorities, dependencies, and milestones to support successful software delivery
Coordinate day-to-day execution with a hands-on approach, engaging directly with teams to drive progress, remove blockers, and maintain alignment to sprint and release goals
Facilitate software project meetings, planning activities, release readiness reviews, and Agile ceremonies as needed
Coordinate cross-functional teams to ensure alignment on roles, priorities, scope, dependencies, and risks
Provide updates and escalating constraints to Product Development Leadership
Communicate clearly and proactively with stakeholders, tailoring messaging across technical, clinical, regulatory, and leadership audiences
Organize release readiness activities and reviews in accordance with the Software Development Process
Support the planning, tracking, and delivery of all software release documentation and DHF deliverables; ensure completeness, accuracy, and audit readiness across the full release lifecycle
Maintain project and release dashboards, defining and monitoring key metrics to provide real-time visibility into scope, progress, risks, and release readiness
Apply phase-gate and milestone-driven product development principles to ensure project documentation and processes meet regulatory requirements